Shimadzu contributes to PCR testing for the novel coronavirus by releasing a world-first pooled-sample preprocessing and testing device for medical applications

On January 6, Shimadzu Corporation released the sample pretreatment device Amprep (general medical device "Class I") for pooled sample testing in Japan. The suggested sales price is 1.5 million yen (PC and taxes not included). The company plans to sell 500 units of this device in the next financial year. The new product prepares individual samples (saliva, nasopharyngeal swabs) for pooled samples testing in a minimum of 15 minutes. A maximum of 20 individual samples can be used, and up to four pooled samples (five individual samples per pooled sample) can be prepared simultaneously. When used in conjunction with genetic analysis using AutoAmp, a PCR device also developed by Shimadzu, Amprep makes it easier to manage individual and pooled specimen data. Amprep requires 15 minutes for preparing one pooled sample (with five individual samples) and 35 minutes for preparing four pooled samples (with five individual samples each).

In pooled testing, pooled samples, in which several individual samples are mixed together, are tested. This reduces the time and cost required for testing. When a pooled sample yields positive results in the test, each individual sample within the pool is tested to identify the sample(s) responsible for the positive result. This method is ideal for screening during periods of low positivity. The new device reduces the chances of direct contact of laboratory personnel with specimens by automating human-mediated tasks in the preparation of pooled specimens, including sample dispensing and mixing.

In November 2020, Shimadzu launched AutoAmp, a genetic analyzer for use in clinics. By the end of December 2021, a total of more than 1,200 units of AutoAmp were shipped. AutoAmp is a fully automated real-time PCR device characterized by simple operation and low price and detects the novel coronavirus (SARS-CoV-2) using the in vitro diagnostic kit Ampdirect 2019-nCoV. The new product "Amprep" has been developed based on the "AutoAmp" mechanism; the appearance of these devices and the floor area they cover are the same; both devices are easy to place in a small space. The dimensions of the device are 305 mm width × 655 mm depth × 660 mm height. Pooled samples prepared using "Amprep" can be set in "AutoAmp" as they are, and transfer of sample information from "Amprep" to "AutoAmp" using dedicated software can improve the testing efficiency. One computer can control one "Amprep" and up to four "AutoAmp" devices at a time.

■ AutoAmp is only available in Japan.